UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014789 |
|---|---|
| Receipt number | R000017195 |
| Scientific Title | A prospective study to explore the relationship between SPARC expression and efficacy of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer (SYNAPSE study) |
| Date of disclosure of the study information | 2014/08/08 |
| Last modified on | 2020/11/16 19:30:33 |
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Basic information
Public title
A prospective study to explore the relationship between SPARC expression and efficacy of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer (SYNAPSE study)
Acronym
A prospective study to explore the relationship between SPARC expression and efficacy of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer (SYNAPSE study)
Scientific Title
A prospective study to explore the relationship between SPARC expression and efficacy of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer (SYNAPSE study)
Scientific Title:Acronym
A prospective study to explore the relationship between SPARC expression and efficacy of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer (SYNAPSE study)
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the correlation between the expression of SPARC and the efficacy of nab-paclitaxel as second-line chemotherapy for metastatic or recurrent gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall Survival according to SPARC expression
Key secondary outcomes
Progression Free Survival
Time to Treatment Failure
Response Rate
Disease Control Rate
Dose Intensity
Adverse Event
Clinicopathological Characteristics of SPARC expression
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
nab-paclitaxel
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histlogically confirmed gastric adenocarcinoma
2) Unresectable or recurrent gastric cancer
3) No previous chemotherapy for other malignancies
4) Prior chemotherapy consisted of fluoropyrimidine for unresectable or reccurent gastric cancer
5) No past history of treatment related taxan
6) Age : 20 years old and more
7) ECOG Performance Status 0-2
8) Liffe expectancy : 90 days and more
9) Adequate organ function as evidenced by the follow laboratory studies within 28 days prior to enrollment
a)Neutrophil conunt : 1,500 /mm3 or above
b)Platet count : 100,000 /mm3 or above
c) Hemoglobin : 8.0 g/dL or above
d) Total bilirubin : 1.5 mg/dL or less
e) AST(GOT) : 100 IU/L or less (200 IU/L or less in patients with liver metastasis)
f) ALT(GPT) : 100 IU/L or less (200 IU/L or less in patients with liver metastasis)
g) Serum creatinine : 1.5 mg/dL or less
10) Tumor tissue can be used for this study
11) Written informed consent
Key exclusion criteria
1) Multiple primary cancers with disease-free period less than 5-years, except carcinoma in situ or intra mucosal disease cured by local therapy
2) Past history of severe hypersensitivity to drug
3) Active incection
4) Fever more than 38 degree
5) Central nervous system metastasis or carcinomatous meningitis
6) Massive cardiac effusion, pleural effusion or ascites
7) Peripheral sensory neuropathy : grade 2 or above (CTCAE v4.0)
8) Chronic daily treatment with oral or intravenous corticosteroids
9) Unstable angina or past history of myocardinal infraction in 6 months
10) Evidence of any other serious disease ; renal failure, hepatic failure, interstinal pneumonitis or lung fibrosis
11) Pregnant, lactating female, female of childbearing potential or male without contracepcion intention
12) Psychiatric disease that is inapprocpriate for entry into this study
13) Any patients judged by the investigator to be unfit to participate in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Yamashita |
Organization
Sapporo Medical University
Division name
Department of Gastroenterology, Rheumatology and Clinical Immunology
Zip code
Address
South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan
TEL
+81-11-611-2111
ykentaro@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Onodera |
Organization
Sapporo Medical University
Division name
Department of Gastroenterology, Rheumatology and Clinical Immunology
Zip code
Address
South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan
TEL
+81-11-611-2111
Homepage URL
konodera@sapmed.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Rheumatology and Clinical Immunology, Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Rheumatology and Clinical Immunology, Sapporo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 07 | Day |
Last modified on
| 2020 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017195
